Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-30 @ 4:47 PM
Study NCT ID:
NCT01306435
Status:
COMPLETED
Last Update Posted:
2011-03-01
First Post:
2011-02-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Power Laser and Exercise in Osteoarthritis of the Knee: a Randomized Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007834', 'term': 'Lasers'}, {'id': 'D028022', 'term': 'Low-Level Light Therapy'}], 'ancestors': [{'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}, {'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-28', 'studyFirstSubmitDate': '2011-02-23', 'studyFirstSubmitQcDate': '2011-02-28', 'lastUpdatePostDateStruct': {'date': '2011-03-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in VAS at 3 and 8 weeks', 'timeFrame': 'baseline, 3 and 8 weeks', 'description': 'In the VAS the subject marks the intensity of its pain in a centimeter horizontal line'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Lequesne at 3 an 8 weeks', 'timeFrame': 'baseline, 3 and 8 weeks', 'description': 'Lequesne index is a composite of 11 questions about pain, discomfort and function. The scores range from 0 to 24 (without affecting the extremely severe, respectively), the higher the score, the greater the impairment.'}, {'measure': 'Change from baseline in range of motion', 'timeFrame': 'baseline, 3 and 8 weeks', 'description': 'ADM flexion and knee extension was measured using a universal goniometer (AESCULAP) with the patient prone'}, {'measure': 'Change from baseline in Muscular Strength at 3 and 8 weeks', 'timeFrame': 'baseline, 3 and 8 weeks', 'description': 'To assess the maximal isometric strength of the quadriceps muscle was used Dynamometer model Lafayette ® Portable (USA), while seated at 60 ° of knee flexion and this gradation was controlled with a goniometer. Patients remained seated on the stretcher and held steady with thigh extension strength, the dynamometer being maintained in the distal leg. Three measurements were taken, and the mean value'}, {'measure': 'Change from baseline in Quality of Life at 3 and 8 weeks', 'timeFrame': 'baseline, 3 and 8 weeks', 'description': 'The Questionnaire was used Western Ontario and McMaster Universities Osteoarthritis (WOMAC) a self-assessment that evaluates pain, stiffness and physical activity. The higher the score, the greater the impact of OA on quality of life.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Osteoarthritis', 'Low Power Laser Therapy', 'Exercise', 'Knee'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Indroduction: Knee osteoarthritis (OA) is a painful condition causing disability, weakness and poor quality of live. The results are very consistent about the benefits of laser and exercises to improve pain and function in subjects with knee osteoarthritis Objectives: To investigate the effects of Low Power Laser (LBP) associated with exercise in pain, function, range of motion, muscle strength and quality of life of patients with knee osteoarthritis.\n\nMethods: Forty patients of both sexes aged between 50 and 75 years with knee osteoarthritis (grade 2-4) were randomized into two groups: Laser-LBP-active dose of 3J more exercises and Group Placebo-LBP- placebo and exercise. Were evaluated for pain, function, range of motion, muscle strength and quality of life on three occasions: before starting treatment (evaluation 1), 3 weeks after laser application (evaluation 2) and 8 weeks after completion of exercise (evaluation 3). There were 33 physical therapy sessions three times a week, on March 1 and the laser was applied in the other, only the exercises.', 'detailedDescription': 'Pain: Pain intensity was measured with the Visual Analogue Scale (VAS) which is a straight 10 cm long devoid of numbers, in which there is only an indication of the extreme left of "no pain" and extreme right to "unbearable pain". The higher the score, the greater the pain.\n\nFeature: Survey conducted by Lequesne, which is an index composed of 11 questions about pain, discomfort and function. The scores range from 0 to 24 (without affecting the extremely severe, respectively), the higher the score, the greater the impairment.\n\nRange of motion (ROM): ADM flexion and knee extension was measured using a universal goniometer (AESCULAP) with the patient prone second methodology Marques.\n\nMuscular Strength: To assess the maximal isometric strength of the quadriceps muscle was used Dynamometer model Lafayette ® Portable (USA), while seated at 60 ° of knee flexion and this gradation was controlled with a goniometer. Patients remained seated on the stretcher and held steady with thigh extension strength, the dynamometer being maintained in the distal leg. Three measurements were taken, and the mean value.\n\nQuality of Life: The Questionnaire was used Western Ontario and McMaster Universities Osteoarthritis (WOMAC)a self-assessment that evaluates pain, stiffness and physical activity. The higher the score, the greater the impact of OA on quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnoses of osteoarthritis\n* Knee pain\n* Functional reduction in the last three months\n* Grade 2-4 OA\n* Fulfilled at least one of the classification criteria of the American College of Rheumatology\n\nExclusion Criteria:\n\n* Cancer\n* Diabetes mellitus\n* Symptomatic hip OA\n* Antidepressants\n* Anti-inflammatory steroidal and nonsteroidal or tranquilizers in the last six months and throughout the treatment'}, 'identificationModule': {'nctId': 'NCT01306435', 'briefTitle': 'Low Power Laser and Exercise in Osteoarthritis of the Knee: a Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Effects of Low Power Laser Associated With Exercises in Osteoartite Knee: Randomized Clinical Trial, Double-blind, Controlled', 'orgStudyIdInfo': {'id': '077508'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laser Group', 'interventionNames': ['Other: Laser']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'interventionNames': ['Other: Placebo Laser']}], 'interventions': [{'name': 'Laser', 'type': 'OTHER', 'otherNames': ['LOW POWER LASER'], 'description': '3-week treatment with three Laser sessions per week', 'armGroupLabels': ['Laser Group']}, {'name': 'Placebo Laser', 'type': 'OTHER', 'otherNames': ['PLACEBO LOW POWER LASER'], 'description': '3-week treatment with three Placebo Laser sessions per week', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'University of São Paulo General Hospital', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Patrícia P Alfredo, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine of the University of São Paulo'}, {'name': 'Amélia P Marques, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Medicine of the University of São Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Amélia Pasqual Marques', 'oldOrganization': 'Departamnto Speech Therapy, Physiotherapy and Occupational Therapy, Faculty of Medicine, University of São Paulo, Brazil'}}}}